DIPEN INJECTION
Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
31-05-2024
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Virkt innihaldsefni:
PROCAINE BENZYLPENICILLIN DIHYDROSTREPTOMYCIN SULFATE
Fáanlegur frá:
Bimeda Chemicals
ATC númer:
QJ01RA01
Lyfjaform:
Suspension for Injection
Meðferðarhópur:
Antibacterial
Lækningarsvæði:
Bovine
Leyfisdagur:
1987-10-01
Vara einkenni
IRISH MEDICINES BOARD ACT 1995
ANIMAL REMEDIES REGULATIONS, 2005
(S.I. NO. 734 OF 2005)
VPA: 10126/005/001
Case No: 7002810
The Irish Medicines Board in exercise of the powers conferred on it by Animal Remedies Regulations (S.I. No. 734 of 2005) hereby grants to:
BIMEDA CHEMICALS
BROOMHILL ROAD, TALLAGHT, DUBLIN 24., IRELAND
an authorisation, subject to the provisions of the said Regulations and the general conditions of the attached authorisation, in respect of the
Veterinary Medicinal Product:
DIPEN INJECTION
The particulars of which are set out in Part 1 and Part 2 of the said Schedule. The authorisation is also subject to any special conditions as may
be specified in the said Schedule.
Signed on behalf of the Irish Medicines Board
________________
A person authorised in that behalf by the said Board.
(NOTE: This authorisation replaces any previous authorisation in respect of this product which is now null and void.)
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 23/01/2007_
_CRN 7002810_
_page number: 1_
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dipen Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, Sheep and Pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of infections caused by organisms sensitive to penicillin and dihydrostreptomycin. These include
both gram positive and gram negative organisms as follows:
Each ml contains:
Active Substances
Procaine Benzylpenicillin
150.0 mg
Dihydrostreptomycin
150.0 mg
(as Dihydrostreptomycin Sulphate)
Excipients
Methyl Parahydroxybenzoate
1.0
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